A NOVEL REVERSE PHASE LIQUID CHROMATOGRAPHIC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ATORVASTATIN, EZETIMIBE AND FENOFIBRATE IN BULK AND TABLET DOSAGE FORMAbstract
A novel reverse phase liquid chromatographic method has been developed for the simultaneous estimation of Atorvastatin Calcium, Ezetimibe and Fenofibrate in bulk and Pharmaceutical formulations by using reverse phase Agilent 100-5 C18 column [250mm x 4.6mm]. The mobile phase (Methanol: water) in the ratio of 70:30% v/v was pumped at a flow rate of 1ml/min and the column effluents were monitored at 250nm using Variable Wavelength UV detector. Linearity was obtained in the concentration range of 20-100 µg/ml for Atorvastatin and Ezetimibe and 50-250µg/ml for Fenofibrate. The established method was statistically validated according to the ICH Q2B guidelines and the percentage relative standard deviation for precision, robustness and ruggedness was found to be less than 2% indicating high degree of precision and robustness. The percentage recovery for the accuracy was found to be 100.52%, 100.45% and 101.31% for Atorvastatin, Ezetimibe and Fenofibrate respectively which were within the specified limits of recovery. Assay for the marketed formulation proved that 99.86% of Atorvastatin, 99.61% of Ezetimibe and 99.83% of Fenofibrate. Hence due to its simplicity, rapidity, precision and accuracy the developed HPLC method can be applied for the estimation of Atorvastatin, Ezetimibe and Fenofibrate in pure and marketed formulations by a modern analyst.
B. Praveen Kumar *, S. Vidyadhara , T. E. G. K. Murthy, B. Venkateswara Rao and V. Nikhila
Department of Pharmaceutical Analysis 1, Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Chandramoulipuram, Chowdavaram, Guntur, Andhra Pradesh, India
27 April, 2016
17 September, 2016
23 September, 2016
01 October 2016